UMIN-CTR Clinical Trial

Public title

A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services

Acronym

A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services

Scientific Title

A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services

Scientific Title:Acronym

A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services

Region

Japan

Condition

autism spectrum disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

People with autism spectrum disorder (ASD) lack the inherent ability to automatically read the atmosphere in a room, respond to it, or to enjoy social interaction (this is why ASD is categorized as a condition in which theory of the mind is not functioning). As a result, people with ASD have difficulty forming interpersonal relationships and they often have secondary disorders. In addition, drug therapy for ASD is symptomatic treatment, so people with ASD need psychosocial support. Training in communication skills and socializing is an extremely vital part of that support. A communication program for adults with ASD was developed at Showa University is Karasuyama Hospital as a standardized therapy, and this program has yielded results. The program is conducted in a total of 20 weekly sessions. That said, the traffic network in Kochi Prefecture is lacking in comparison to that in urban areas, and participants often have difficulty visiting the hospital weekly.
Given these facts, needs could potentially be met by providing a Web-based communication program for people with ASD. Accordingly, this study is exploring the feasibility of such a program. The Internet has clearly permeated society. According to a Ministry of Internal Affairs and Communications survey, there were over 100 million Internet users in Japan in 2017, and over 90 percent of people ages 13-59 use the Internet.
A remote intervention using the Internet avoids geographical constraints, which makes it advantageous as a support option. This intervention can be performed if a subject is connected to the Internet. However, no studies have examined an online communication program for people with ASD. The aim of this study is to examine the feasibility of an online program. In addition, this study seeks to compare the effectiveness of the program to that of a conventional face-to-face program.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Interpersonal Reactivity Index Japanese version(It is before and after intervention)

Key secondary outcomes

Autism Spectrum Question(It is before and after intervention)
WHO Quality of Life 26(It is before and after intervention)
social functioning scale japanese version(It is before and after intervention)
General Self Esteem Score(It is before and after intervention)
a survey(It is before and after intervention)
wechsler adult intelligence scale-third edutuon
Social Communication Questionnaire(It is before and after intervention)
Grobal Assessment of Functioning Scale(It is before and after intervention)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Subjects will be adults who meet the inclusion criteria and who consent to participate in this study.A communication program will be conducted as part of zoom.The program will be conducted in weekly sessions of about an hour and a half.One round of the program will last 5 months,for a total of 20 sessions.A group will consist of up to 5 individuals.
A communication program for adults on the autism spectrum
The Ministry of Health,Labour and Welfare is 2014 Project to Promote Comprehensive Welfare for Persons with Disabilities at Showa University Karasuyama Hospital indicated:1.that the program was effective,2.that characteristics of autism were alleviated after participation in the program,3.that participants communicated more,and 4.that the program may improve quality of life for participants.
Procedures for this study
Subjects will be adults who meet the inclusion criteria and who consent to participate in this study.
A questionnaire (AQ, SFS-J, IRI-J and a WHOQOL26,GSES,a survey) will be distributed to subjects for them to complete, intake interviews will be conducted, and the SCQ will be administered to a person who brings up a patient or a partner.
The WAIS-3 will be administered
They install zoom
I transmit a message on the communication program day before
Sessions will be conducted weekly for about an hour and a half
They log in at designation time.A session will consist of a starting meeting, submission and checking of homework, confirmation of what the program entails (confirmation of what the program entails and an explanation of rules, specification of a set topic for each session, and previous homework), and a farewell meeting
Once all 20 sessions end, a questionnaire will be distributed to subjects for them to complete (AQ, SFS-J, IRI-J and a WHOQOL26,GSES,a survey, and a survey after all of the sessions have ended), and the SCQ will be administered to a person who brings up a patient or a partner.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

Outpatients who have been diagnosed with autism spectrum disorder
Individuals diagnosed with an autism spectrum disorder
Individuals should ages 18-50
Both sexes may participate
Individuals with stable comorbidities and individuals whose medication has changed little up to 1 month prior to enrollment (Global Assessment of Functioning (GAF) score of 51 or higher)
Individuals who are connected to the Internet

Key exclusion criteria

Individuals with intense suicidal ideation or individuals with a mental state (secondary disorder) hampering an understanding of this study
Individuals who were severely injured within the past 3 months
Individuals with an unstable condition who are likely to be hospitalized (GAF score below 50)

Target sample size

15

Name of lead principal investigator

1st name	yukiko
Middle name
Last name	tomari

Organization

kochi medical school

Division name

department of neuropsychiatry(rehabilitation center)

Zip code

780-8072

Address

kohasu oko-cho,nankoku,kochi 783-8505

TEL

088-880-2359

Email

jm-tomari@kochi-u.ac.jp

Name of contact person

1st name	yukiko
Middle name
Last name	tomari

Organization

kochi medical school

Division name

department of neuropsychiatry(rehabilitation center)

Zip code

780-8072

Address

kohasu oko-cho,nankoku,kochi 783-8505

TEL

088-880-2359

Homepage URL

Email

jm-tomari@kochi-u.ac.jp

Institute

kochi medical school

Institute

Department

Personal name

Organization

no

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

kochi medical school

Address

kohasu oko-cho,nankoku,kochi 783-8505

Tel

088-880-2359

Email

jm-tomari@kochi-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2019

Year

10

Month

29

Day

Date of IRB

Anticipated trial start date

2019

Year

11

Month

30

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

10

Month

28

Day

Last modified on

2020

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042541